Rosacea Clinical Trial
Official title:
Skin Imaging to Inform Laser Treatments
Verified date | November 2023 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to obtain information (such as lesion depth, depth of the most superficial part of the lesion, and the size and density of blood vessels) with the assistance of an imaging device, and use this information to assist in selection of laser settings for the treatment of skin conditions. The imaging modality is called Optical Coherence Tomography (OCT). Multiple laser modalities will be used, including intense pulsed light lasers (BroadBand Light, Profractional Sciton), pulsed dye lasers (Vbeam Perfecta, Candela), long-pulse 755nm lasers (GentleLASE, Candela), Sciton long-pulse 1064nm lasers, and non-ablative and ablative fractional resurfacing lasers (Profractional, Sciton). All of the lasers noted above are the only ones that will be used in this study. These lasers have 510k clearance and are being used as per their approved indications in this study. The choice of laser type is based on the skin lesion and is recommended by the physician, and the subjects who are going to enroll in this study will already be planned to undergo laser treatment as a standard of care for their condition. This is a pilot study that will explore the utility of skin imaging in guiding the laser treatment of skin lesions.
Status | Terminated |
Enrollment | 55 |
Est. completion date | July 8, 2022 |
Est. primary completion date | July 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria Subjects must meet the following inclusion criteria: - Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative. - Ages 4 and older. Patients younger than 4 may have difficulty cooperating with the OCT measurements because each measurement requires the patient to remain still for approximately 30 seconds. - Seeks and is scheduled for laser treatment of a skin lesion. Exclusion Criteria Any of the following will exclude participation in the study: - Inability to understand and/or carry out subject instructions. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
Aldahan AS, Chen LL, Tsatalis JP, Grichnik JM. Optical Coherence Tomography Visualization of a Port-Wine Stain in a Patient With Sturge-Weber Syndrome. Dermatol Surg. 2017 Jun;43(6):889-891. doi: 10.1097/DSS.0000000000001055. No abstract available. — View Citation
Aldahan AS, Mlacker S, Shah VV, Chen LL, Nouri K, Grichnik JM. Utilization of Optical Coherence Tomography in the Evaluation of Cherry Hemangiomas. J Drugs Dermatol. 2016 Jun 1;15(6):713-4. — View Citation
Banzhaf CA, Thaysen-Petersen D, Bay C, Philipsen PA, Mogensen M, Prow T, Haedersdal M. Fractional laser-assisted drug uptake: Impact of time-related topical application to achieve enhanced delivery. Lasers Surg Med. 2017 Apr;49(4):348-354. doi: 10.1002/ls — View Citation
Byers RA, Fisher M, Brown NJ, Tozer GM, Matcher SJ. Vascular patterning of subcutaneous mouse fibrosarcomas expressing individual VEGF isoforms can be differentiated using angiographic optical coherence tomography. Biomed Opt Express. 2017 Sep 19;8(10):45 — View Citation
Mogensen M, Bojesen S, Israelsen NM, Maria M, Jensen M, Podoleanu A, Bang O, Haedersdal M. Two optical coherence tomography systems detect topical gold nanoshells in hair follicles, sweat ducts and measure epidermis. J Biophotonics. 2018 Sep;11(9):e201700 — View Citation
Olesen UH, Mogensen M, Haedersdal M. Vehicle type affects filling of fractional laser-ablated channels imaged by optical coherence tomography. Lasers Med Sci. 2017 Apr;32(3):679-684. doi: 10.1007/s10103-017-2168-z. Epub 2017 Feb 17. — View Citation
Ring HC, Mogensen M, Banzhaf C, Themstrup L, Jemec GB. Optical coherence tomography imaging of telangiectasias during intense pulsed light treatment: a potential tool for rapid outcome assessment. Arch Dermatol Res. 2013 May;305(4):299-303. doi: 10.1007/s — View Citation
Themstrup L, Ciardo S, Manfredi M, Ulrich M, Pellacani G, Welzel J, Jemec GB. In vivo, micro-morphological vascular changes induced by topical brimonidine studied by Dynamic optical coherence tomography. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):974-9. — View Citation
Themstrup L, Welzel J, Ciardo S, Kaestle R, Ulrich M, Holmes J, Whitehead R, Sattler EC, Kindermann N, Pellacani G, Jemec GB. Validation of Dynamic optical coherence tomography for non-invasive, in vivo microcirculation imaging of the skin. Microvasc Res. — View Citation
Urban J, Siripunvarapon AH, Meekings A, Kalowitz A, Markowitz O. Optical coherence tomography imaging of erythematotelangiectatic rosacea during treatment with brimonidine topical gel 0.33%: a potential method for treatment outcome assessment. J Drugs Der — View Citation
Waibel JS, Holmes J, Rudnick A, Woods D, Kelly KM. Angiographic optical coherence tomography imaging of hemangiomas and port wine birthmarks. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22816. Online ahead of print. — View Citation
Waibel JS, Rudnick AC, Wulkan AJ, Holmes JD. The Diagnostic Role of Optical Coherence Tomography (OCT) in Measuring the Depth of Burn and Traumatic Scars for More Accurate Laser Dosimetry: Pilot Study. J Drugs Dermatol. 2016 Nov 1;15(11):1375-1380. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Scarring, Blistering, Bruising, and Scabbing | Any adverse effects of treatment such as scarring, blistering, bruising, and scabbing. | Through study completion; average of one year | |
Primary | Assessment of Change in Photographed Lesion | Primary outcome variable includes assessment of change in photographed lesion. Two board-certified dermatologists will grade the degree of change of the photographed lesion in quartiles (no change or darkening=0-25, mild lightening=26-50, good lightening=51-75, excellent lightening=76-95, complete resolution=96-100). | Through study completion; average of one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05597462 -
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
|
Phase 1 | |
Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT02249065 -
Mirvaso in Use Study
|
Phase 4 | |
Completed |
NCT02292797 -
Assessment of the Rosacea Prevalence in the General Population
|
N/A | |
Completed |
NCT01659853 -
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
|
Phase 3 | |
Completed |
NCT01426269 -
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
|
Phase 4 | |
Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 | |
Recruiting |
NCT04108897 -
Analysis of the Microbiome in Rosacea
|
Early Phase 1 | |
Completed |
NCT03872050 -
Deep Phenotyping of Rosacea and Migraine
|
||
Active, not recruiting |
NCT06033352 -
Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT04508660 -
CGB-400 for the Reduction of Facial Redness
|
Phase 1 | |
Completed |
NCT04508205 -
CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes
|
Phase 1 | |
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
Active, not recruiting |
NCT03211585 -
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
|
N/A | |
Completed |
NCT02576860 -
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
|
Phase 3 | |
Completed |
NCT02637232 -
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
|
||
Completed |
NCT02576847 -
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
|
Phase 3 | |
Completed |
NCT02583009 -
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
|
Phase 2 | |
Completed |
NCT01993446 -
A Safety and Efficacy Study of DRM02 in Subjects With Rosacea
|
Phase 2 |